Director - QA IAPI

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.  #WeAreLilly

Responsibilities:

The Associate Director – Quality Assurance (QA) is responsible for managing the activities of QA personnel supporting the oversight of Insulin or Peptide Purification Active Pharmaceutical Ingredient (API) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site. The Associate Director – QA is primarily responsible for the productivity and development of the QA employees, the quality of the product/results, oversight of manufacturing and support operations and overall customer service.  It is expected that the Associate Director will oversee the department’s performance, resolution of quality issues, and regulatory compliance. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation.  The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.

• Inspection Readiness focus through developing and maintaining processes that support inspections and audits; prepare individuals to interact with inspectors and auditors. Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency inspections.
• Conduct performance management and development of QA staff;
• Partner within QA and across functional disciplines to influence and implement the site continuous improvements,  site business plan objectives, and GMP Quality Plan objectives
• Provide coaching/feedback to and develop QA employees.
• Utilize Human Resources tools to ensure that the right individuals are in the right job (e.g., Performance Management, Merit Delivery, Talent Assessment, Succession Planning and Staffing).
• Participate in organizational planning.
• Provide input into the business plan and ensure conformance to department budget for area of responsibility.
• Exhibit cross-functional influence.
• Maintain and improve quality systems.
• Review and approve deviations, procedures, protocols, and change controls with focus for improving the overall manufacturing and/or business processes
• Participate in self assessments and regulatory agency inspections.
• Ensure internal and external quality and supply commitments are met.
• Provide quality management oversight for API manufacturing, laboratories and warehouses.
• Investigate complaints.
• Manage the creation, revision and maintenance of cGMP documents (e.g., job aids, procedures, forms, job descriptions).
• Provide oversight and review of changes to the Global Quality Standards and ensure local implementation of changes.
• Network with other sites regarding new or current quality systems.

Basic Qualifications:

• Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field.

• 5+ years of experience in pharmaceutical manufacturing environment in any of the follow